Sr. Compliance Specialist

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Patheon, Bio Services Division, St. Louis, MO

How will you make an impact?

This role is responsible for site inspection readiness, conducting internal audits of Quality systems and GMP functions, facilitation of client audits, and implementation and tracking of corrective actions. This individual ensures compliance with FDA, EMA and other cGMP regulations, including client requirements.

Responsibilities

Ensure the site’s compliance with FDA, EMA and other cGMP regulations, including client requirements.

• Actively lead and participate in site inspection readiness program and execution of regulatory inspections.
• Lead site internal audits including executing, response approval, and tracking remediation activities.
• Facilitate client audits including preparing, hosting, response development, and tracking closeout activities.
• Approve corrective action plans for identified Quality System CAPAs.
• Lead client Pre-License Inspection readiness activities as the client point of contact.
• Provide interpretation and guidance to the site with respect to current regulations.
• Provide knowledge of current cGMP requirements and trends to ensure that the appropriate technical support on all quality/compliance related matters is provided to the site.
• Train and mentor junior staff members.

Education

Bachelor’s degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required.

Experience

• 7+ years within a GMP Environment (pharmaceutical preferred)
• 5 + years of experience within Quality Assurance or Compliance required
• At least 2 years of experience in conducting internal audits required
• In-depth knowledge of FDA/EMA regulatory requirements required
• Strong understanding of Quality Management Systems is required
• Previous experience with hosting client audits and/or regulatory inspections required

Knowledge, Skills, Abilities

• Well organized, detailed oriented, and strong time management skills
• Strong communication and presentation skills, including proficiency with written regulatory/client responses
• Ability to interact and collaborate with all levels of the organization and clients
• Ability to identify and facilitate opportunities for quality improvements

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.